Hamburg’s Public Farewell Includes Rallying Cry For FDA Power
This article was originally published in The Rose Sheet
Outgoing commissioner gives a forceful defense of the agency’s regulatory authority and warns that lowering drug approval standards would be detrimental to both patients and industry.
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Margaret Hamburg’s background in public health, as opposed to academic medicine, was off-putting to some in pharma initially, but she’ll leave the agency in March with high drug approval numbers and praise from industry groups. Chief Scientist Stephen Ostroff has been named acting head, and some speculate that Robert Califf, newly appointed deputy commissioner for medical products and tobacco, is in line to succeed Hamburg on a permanent basis.
Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.
Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.